Most Prohormones May be Gone in SIX Months!
- 03-12-2011, 06:44 PM
I think it's a bit lame to throw out a "scare topic" like this and then say ... "If you like any IronMagLabs products I suggest you start stock piling them."
Well ... I guess it's not that lame ... it's a pretty successful tactic in selling guns and ammo.
Just a suggestion though - since the OP is a board sponsor for IronMagLabs - a bit better sourcing for this would be a good idea. I'll note here that the OP's post begins with a falsehood ...
The Dietary Supplement Safety Act of 2010 has been approved and awaits President Obama's signature.
When this inaccuracy was pointed out to the OP - then a new assertion was thrown out that the essential horrible elements had been rolled into a Food Safety Bill and then passed in that. Well yes - a Food Safety Bill was passed - but I see nothing in it that says that all pro hormones are now banned. I only gave it a cursory look - it's a long bill. Could it be in there - yes I suppose it could be - and if it is - then why doesn't the OP quote the applicable portions of that bill - tell us on what page we can find the ban.
Before making assertions like this - it would be nice if some original sources were quoted.
- 03-12-2011, 08:40 PM
Well he did say they may be gone... From what I hear too it sounds like most companies will stop producing them regardless.
- 03-12-2011, 09:03 PM
The new law from my understanding gives new and more powers to the FDA. One of which allows them to no longer have to send a voluntary recall letter, but to enact the recall themselves. Also they will be able to fine these companies and or owners themselves. There are other ones that can affect the supplement market as well. The issue here is that the FDA will have more power, and lets face it the FDA is always cracking down on the supplement market.
03-12-2011, 09:34 PM
Google is a magical thing...
S. 3002 [111th]: Dietary Supplement Safety Act of 2010 (GovTrack.us)
http://mccain.senate.gov/public/inde...f-8318a24f718fStatus: Introduced Feb 4, 2010 (completed)
Referred to Committee View Committee Assignments (completed)
Reported by Committee (did not occur)
Senate Vote (did not occur)
House Vote (did not occur)
Signed by President (did not occur)
This bill never became law. This bill was proposed in a previous session of Congress. Sessions of Congress last two years, and at the end of each session all proposed bills and resolutions that haven't passed are cleared from the books. Members often reintroduce bills that did not come up for debate under a new number in the next session.
Last Action: Feb 4, 2010: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
also a little searching and I found this
S. 722 [108th]: Dietary Supplement Safety Act of 2003 (GovTrack.us)
It appears this bill has been tried before in 2003 and died just like McCains so this is not the first time it has come up
Also looks like this a recent testimony before congress on supplement regulation if anyone cares to read through all those pages.. If anyone does please provide us with a cliff notes version
Dietary Supplement Safety Act: How is FDA Doing 10 Years Later
"The only good is knowledge and the only evil is ignorance." - Socrates
03-12-2011, 09:59 PM
03-12-2011, 10:05 PM
Now - once that was pointed out - focus then shifted in this thread to the Food Safety Act but, I'm sorry - simply saying that devastating things are in that act is not enough. If anyone's going to assert that - then they need to post the actual applicable sections of that act as proof.
EDIT: Not saying that this is entirely bogus - just saying that those who are asserting this haven't quite proven the point yet. They very well could - it's a long bill and who knows what's in it.
03-12-2011, 10:19 PM
I do know that the FDA is now bringing forth criminal charges for makers and distributors of SD, they are also working with Homeland Security/DEA to investigate these cases.
03-12-2011, 10:34 PM
So do you know if the premise of the bill McCain proposed is whats being included into the food bill or is it entirely different concept? (Being the same requirement for FDA approval for everything and more regulations)
"The only good is knowledge and the only evil is ignorance." - Socrates
03-12-2011, 10:40 PM
03-12-2011, 10:48 PM
Again I have not seen the actual bill so I honestly dont know too much just going off what I have read before. Didnt know supplements were included in it, I may have to try and look this up again
"The only good is knowledge and the only evil is ignorance." - Socrates
03-12-2011, 10:57 PM
03-12-2011, 11:03 PM
So is this the food safety bill you guys are talking about? If so it did pass and the president did sign it jan 4 http://www.govtrack.us/congress/bill.xpd?bill=h111-2751
Not sure what the bill includes. Here is an abstract
For full text of the bill click here ---> http://frwebgate.access.gpo.gov/cgi-...751eas.txt.pdf1/4/2011--Public Law. (This measure has not been amended since it was passed by the Senate on November 30, 2010. The summary of that version is repeated here.) FDA Food Safety Modernization Act -
Title I - Improving Capacity to Prevent Food Safety Problems
Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the food safety activities of the Secretary of Health and Human Services (HHS), including to authorize the Secretary to inspect records related to food. Exempts certain establishments that sell food directly to consumers, such as roadside stands, farmers markets or participants in a community supported agriculture program, from specified requirements of this Act. Requires each owner, operator, or agent in charge of a food facility to identify and implement preventive controls to significantly minimize or prevent hazards that could affect food manufactured, processed, packed, or held by such facility. Sets forth provisions governing exemptions from such requirements for certain facilities. Requires the Secretary to: (1) issue guidance documents to reduce the risk from the most significant foodborne contaminants; and (2) establish minimum standards for the safe production and harvesting of fruits and vegetables based on known safety risks. Authorizes the Secretary to issue exemptions and variances from such standards. Directs the Secretary to assess and collect fees related to: (1) food facility reinspection; (2) food recalls; (3) the voluntary qualified importer program; and (4) importer reinspection. Directs the Secretary to develop voluntary food allergy and anaphylaxis management guidelines for schools and early childhood education programs.
Title II - Improving Capacity to Detect and Respond to Food Safety Problems
Requires the Secretary to: (1) allocate resources to inspect facilities and imported food according to the known safety risks of the facilities or food; and (2) establish a product tracing system to track and trace food that is in the United States or offered for import into the United States. Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to enhance foodborne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on foodborne illnesses. Gives the Secretary the authority to order a recall of an article of food.
Title III - Improving the Safety of Imported Food
Requires U.S. importers to perform risk-based foreign supplier verification activities to verify that imported food is produced in compliance with applicable requirements related to hazard analysis and standards for produce safety and is not adulterated or misbranded. Requires the Secretary to establish a program to expedite review and importation of food offered for importation by U.S. importers who have voluntarily agreed to participate in such program. Authorizes the Secretary to: (1) require a certification that an article of food imported or offered for import complies with applicable requirements of this Act; and (2) enter into arrangements and agreements with foreign governments to facilitate the inspection of registered foreign facilities. Requires food to be refused admission into the United States if permission to inspect the food facility is denied by the facility owner, operator, or agent or the foreign country. Sets forth provisions governing the establishment of a system to recognize bodies that accredit third-party auditors and audit agents to certify that foreign entities meet applicable FFDCA requirements for importation of food into the United States.
Title IV - Miscellaneous Provisions
Authorizes appropriations for FY2011-FY2015 for the activities of the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and related field activities in the Office of Regulatory Affairs of the Food and Drug Administration (FDA). Directs the Secretary to increase the field staff of such Centers and Office. Establishes whistleblower's protections for employees of entities involved in the manufacturing, processing, packing, transporting, distribution, reception, holding, or importation of food who provide information relating to any FFDCA violation.
From the above link via a quick search of the document
IN GENERAL.—If the Secretary determines that the information in a new dietary ingredient notification submitted under this section for an article purported to be a new dietary ingredient is inadquate to establish that a dietary supplement containing such article will reasonably be expected to be safe because the article may be, or may contain, an anabolic steroid or an analogue of an anabolic ster9
oid, the Secretary shall notify the Drug Enforcement Administration of such determination. Such notification by the Secretary shall include, at a minimum, the name of the dietary supplement or article, the name of the person or persons who marketed the product or made the submission of information regarding the article to the Secretary under this section, and any contact information for such person or persons that the
‘‘(2) DEFINITIONS.—For purposes of this subsection— ‘‘(A) the term ‘anabolic steroid’ has the meaning given such term in section 102(41) of the Controlled Substances Act; and ‘‘(B) the term ‘analogue of an anabolic steroid’ means a substance whose chemical structure is substantially similar to the chemical structure of an anabolic steroid.’’ (b) GUIDANCE.—Not later than 180 days after the date of enactment of this Act, the Secretary shall publish guidance that clarifies when a dietary supplement ingredient is a new dietary ingredient, when the manufacturer or distributor of a dietary ingredient or dietary supplement should provide the Secretary with information as described in section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing the identify of a new dietary ingredient.
"The only good is knowledge and the only evil is ignorance." - Socrates
03-12-2011, 11:11 PM
Yup now we are getting to it. Again charges are already being brought to those selling SD. We are talking federal criminal charges here for distribution of steroids.
03-12-2011, 11:14 PM
I don't know about the rest of you all but since I trained supplement free for 20 years I'll chance it.
03-12-2011, 11:25 PM
And yes people are being charged indeed
At the core of FDA’s DSHEA enforcement efforts is our commitment to work with industry in order to encourage the legitimate manufacture, sale, and use of dietary supplements while enforcing the law aggressively against fraudulent product claims and other illegal practices. Dietary supplement enforcement efforts include inspections that have resulted in voluntary compliance, voluntary recalls, warning letters, seizures and injunctions, criminal enforcement, and joint enforcement actions with the Federal Trade Commission (FTC) and the Department of Justice.
FDA shares Federal oversight of dietary supplements with FTC. FDA regulates the safety, manufacturing, and labeling of dietary supplements, while FTC has primary responsibility for regulating the advertising of these products. Over the last few years, FDA and FTC have worked well together to ensure that there is a seamless assertion of our jurisdiction over these products. With the mutual goal of consumer protection, FDA and FTC chair an interagency health fraud steering committee that includes Federal agencies in the U.S., Canada, and Mexico. Also, as part of FDA’s effort to curb Internet health fraud, the Agency has conducted several “surfs” to identify fraudulent marketing of health care products over the Internet. These actions were carried out in partnership with FTC and other law enforcement and public health authorities in the U.S. and abroad.
From October 2002 through April 2004, FDA has conducted 224 domestic inspections of dietary supplement manufacturers, issued more than 170 warning letters and “cyber letters” to marketers of dietary supplement products, seized products worth more than $9 million, supervised the voluntary destruction of more than $3 million worth of products marketed as dietary supplements that were promoted with unsubstantiated claims or that were unapproved drugs, and obtained permanent injunctions against 5 firms distributing misbranded or unapproved drugs as dietary supplements.
FDA enforcement has extended to our nation’s borders, where we have refused importation for more than 1,500 foreign shipments of potentially unsafe or misbranded dietary supplements offered for entry in the U.S. The Agency’s enforcement actions send a clear message that FDA will not tolerate fraudulent practices that victimize or endanger consumers.
As with all of FDA’s activities, priorities are established based upon the direct impact upon public health. Products that present a direct health hazard to consumers are the Agency’s highest priority, although FDA also proceeds against products that present indirect health threats. When the Agency encounters such products, FDA will use all available civil and administrative remedies to assure that the product is quickly removed from the market. We also aggressively publicize our actions to warn consumers and health professionals about such products. In some cases, the Agency may initiate a criminal prosecution against manufacturers or distributors of violative products.
HIGHLIGHTS OF RECENT ENFORCEMENT ACTIONS
Dietary Supplements Promoted Online for Weight Loss
In April 2004, FDA sent warning letters to 16 dietary supplement distributors making false or misleading claims for weight loss products promoted over the Internet. Many of these products claim to block starch, carbohydrates, and fat calories, while maintaining that consumers would lose weight without any changes in lifestyle. For example, some of the product labels have claimed:
“Eat All You Want! Block the Starch and Lose Weight!”
“Neutralize up to 66 percent of the starch consumed in a meal.”
“This advanced dietary-fat inhibitor helps block the absorption of fat calories.”
“Take 3 capsules before bedtime. Watch the fat disappear!”
“Guaranteed to block the breakdown of carbohydrates and simple sugars from being converted into fat.”
Consumer Warning on “Street Drug Alternatives”
On April 9, 2004, FDA issued a Press Release warning consumers not to purchase or consume products that claim to provide “safe legal highs” or that are marketed as “street drug alternatives” by Cytotec Solutions, Inc., of Tampa, Florida. The April 9 th warning expanded on the February 2004 warning concerning a product called Green Hornet, also marketed by Cytotec Solutions, Inc. The products included in this warning were Trip2Night, Invigorate II, Snuffadelic, Liquid Speed, Solar Water, Orange Butterfly, Schoomz and Green Hornet Liquid. The labeling for these products lists a variety of herbal and other ingredients but is incomplete or inaccurate because it does not provide either the name of the manufacturer or the presence of these active drug ingredients.
By way of background on this product type, in 2001, FDA brought a seizure and injunction action against purported supplement firms, Hit Products, Inc., and Organic Diversions, Inc. that marketed products as alternatives to illegal street drugs. The case, U.S. v. Undetermined Quantities of Articles of Drug, Street Drug Alternatives, concerned the firms’ marketing of products made from a mixture of herbs that promised users effects comparable to illegal street drugs. FDA seized these street drug alternatives as misbranded and unapproved new drugs in violation of the FD&C Act. FDA also sought the destruction of the seized goods and an injunction barring defendants from future FD &C Act violations. In granting this relief, the court found FDA’s position on street drug alternatives “highly persuasive” and criticized the defendants’ characterization of the products as dietary supplements as a “veiled attempt to circumvent” the FD&C Act. The court “declined to carve out a statutory loophole for drug manufacturers attempting to profit from the illegal drug epidemic by masquerading potentially dangerous substances as legitimate dietary supplements.”
On March 11, 2004, the Department of Health and Human Services (HHS) Secretary Tommy G. Thompson announced a crackdown on companies that manufacture, market, and distribute products containing androstenedione, or, “andro.” These products act like a steroid once metabolized by the body. As a result they can pose health risks similar to those of steroids. Andro products are generally advertised as dietary supplements that enhance athletic performance based on their claimed anabolic and androgenic properties to stimulate muscle growth and increase production of testosterone.
As part of the crackdown, FDA issued warning letters to 23 companies asking them to cease distributing products sold as dietary supplements that contain androstenedione. The warning letters notified the firms that they could face enforcement actions if they did not take appropriate actions. The warning letters stated that FDA assumed that each firm had a basis to conclude that androstenedione was a dietary ingredient. If androstenedione is a dietary ingredient, FDA believes that it is also a new dietary ingredient for which a pre-market safety notification is required. Because no such notification has been submitted by any manufacturer or distributor who received a warning letter, these products are adulterated and their marketing is prohibited under the FD&C Act.
Conviction Hadi Ghadour
On March 9, 2004, Hadi M. Ghandour pled guilty to conspiracy to introduce misbranded and unapproved new drugs into interstate commerce, counterfeiting human growth hormone, and conspiracy to distribute a controlled substance. Ghandour owned and operated Genapharm, Inc., a distributor of supplements specifically marketed to athletes to enhance performance.
During investigations, Ghandour and his co-conspirators were found to be selling tiratricol, a potent thyroid hormone and Class I health hazard, as a weight-loss drug. Ghandour and his co-conspirators also sold products to people seeking alternatives to street drugs and a veterinary drug used to de-worm animals as an imitation of MDMA (“ecstasy”), a schedule I controlled substance. Ghandour also counterfeited the labels for Nutropin AQ, a human growth hormone manufactured by Genentech, Inc., and placed them on vials containing an insulin mixture.
Ghandour was previously convicted of counterfeiting steroids (misdemeanor) in November of 1998. Two of Ghandour's co-conspirators pled guilty in 2003 and received sentences ranging from probation to three years incarceration. Ghandour faces up to 14 years in prison and a $1,000,000 fine.
"The only good is knowledge and the only evil is ignorance." - Socrates
03-12-2011, 11:28 PM
Consent Decree of Permanent Injunction: Seasilver USA, Inc., and Americaloe, Inc .
On March 8, 2004, the U.S. District Court for the Southern District of California entered a Consent Decree of Permanent Injunction agreed to by the U.S. government, SeaSilver USA, Inc., Americaloe, Inc., of Carlsbad, California, and their principals, Bela Berkes and Jason Berkes. In the Consent Decree, the firms and their representatives agreed to stop manufacturing and distributing violative products, including “Seasilver” – a purported cure-all liquid supplement, and to destroy the seized products at their expense under the supervision of a HHS representative within 60 days of posting bond.
This consent decree followed a coordinated effort in June 2003 between FTC and FDA against Seasilver U.S.A., Inc., and Americaloe, Inc., their owners, and two of the companies’ principal distributors. On June 16, 2003, at FDA’s request, U.S. Marshals seized 132,480 bottles of Seasilver, worth nearly $5.3 million, from Seasilver USA’s San Diego headquarters. Under a settlement with the FTC, entered on March 4, 2004, the Seasilver defendants and the individual distributors agreed to pay $4.5 million in consumer redress.
Regulation Prohibiting Sale of Dietary Supplements Containing Ephedrine Alkaloids
On February 11, 2004, FDA published a regulation declaring dietary supplements containing ephedrine alkaloids (ephedra) adulterated because such supplements present an unreasonable risk of illness or injury. The regulation went into effect on April 12, 2004. This rule is being challenged in court but remains in effect during the challenge.
Guilty Plea – David Hinkson
David Hinkson, the owner of Water Oz, pled guilty to two FDA-related counts. The firm manufacturers and distributes water-based products, labeled as dietary supplements, and ozone generators and body suits which the firm claimed were effective to treat a variety of conditions such as AIDS (Acquired Immuno Deficiency Syndrome) and cancer. In his plea, Hinkson admitted not labeling his lithium water as a drug, despite making drug claims for the product, not labeling the ozone generators as medical devices, and that he did not have approval to market the devices. Sentencing is set for July 29, 2004.
Consumer Warning: Green Hornet, Promoted as Herbal Version of “Ecstasy”
On February 25, 2004, FDA warned consumers not to purchase or consume a liquid product called Green Hornet. This product is promoted on the Internet, and sold in stores, as a herbal version of the illegal street drug “Ecstasy.” FDA considers this product to be an unapproved new drug since it contains, among other ingredients, the undeclared active ingredients diphenhydramine and dextromethorphan, found in over-the-counter (OTC) drugs.
FDA became aware of reports of adverse events experienced by four teenagers after consuming Green Hornet. The teenagers were rushed to a hospital emergency room suffering from seizures, excessive heart rates, severe body rashes and high blood pressure. The Green Hornet product involved in this case was sold by Kekio, Inc., Colorado Springs, Colorado, doing business as a store called Mind Excursions. The store, which also operates a website, has stopped selling the product.
Consent Decree letter issued: Vital Health
A letter was issued on February 19, 2004, to Vital Health of West Allis, Wisconsin, advising the firm that it was found to be in violation of the court judgment filed against it in 1992. FDA found that the firm was actively promoting the sale of Herp-Eeze and TobacOff, products labeled as dietary supplements but promoted with drug claims.
On February 5, 2004, the U.S. Marshal, at the request of FDA, seized approximately 925 bottles of ephedra-containing dietary supplements Betatrim, Thermbuterol, and Stacker 2, from Musclemaster.com in Northboro, Massachusetts. The complaint alleged that Musclemaster.com was making unsubstantiated claims on its websites for the ephedra-containing products. Specifically, it is alleged that Musclemaster.com claimed that its products enhanced the athletic and muscle performance of consumers without adequate scientific basis to support such claims.
Consumer Advisory and Warning Letter: FDA Warns Consumers Not to Feed Infants “Better than Formula Ultra Infant Immune Booster 117”
On January 23, 2004, the Agency issued a warning to consumers that a product, Better Than Formula Ultra Infant Immune Booster 117, sold over the Internet as a dietary supplement should not be fed to infants. Even though NSP Research Nutrition labeled their product as a dietary supplement, FDA is concerned that the product appears to be represented as an infant formula in the product labeling.
On January 30, 2004, FDA issued a warning letter to the firm, advising the firm that it had not filed the necessary documentation for a new infant formula. The letter also advised the firm that the product was misbranded, in that it was labeled as a dietary supplement but did not meet the statutory requirements to be one.
Judgment: Wildflower Pharmacal, Uttam Sethi
Wildflower Pharmacal (now Aulistic Vitamins Corp.) and Uttam Sethi were convicted of three felony counts relating to their manufacturing of dietary supplements that did not contain the labeled amounts of numerous nutrients. Judgment was filed in EDNY on 12/17/03. Mr. Sethi received 5 years probation, $ 3 million fine, and $1.5 million forfeiture. Wildflower Pharmacal received a $2.4 million fine.
Coral Calcium Consent Decree of Condemnation and Permanent Injunction
On December 17, 2003, the U.S. District Court for the Northern District of Illinois entered a Consent Decree of Condemnation and Permanent Injunction against Shop America. The decree prohibits “Shop America and each of its directors, officers, agents, representatives … and any and all persons in active concert from directly or indirectly doing or causing any promoting, representing, or suggesting that an article manufactured, marketed, or distributed by Shop America, is safe or effective in the diagnosis or treatment of cancer, multiple sclerosis, lupus, heart disease, high blood pressure, or any other disease in man or other animals.”
Royal Tongan Limu
In October 2003, FDA witnessed the voluntary destruction of 90,000 bottles worth $2.7 million of Royal Tongan Limu, a liquid dietary supplement distributed by Dynamic Essentials, a subsidiary of NBTY, Inc. The firm was initially warned in a 2002 FDA “cyber letter” that website claims to treat various diseases such as cancer, arthritis, and Attention Deficit Disorder caused their products to be in violation of the law. Despite the warning, the product remained in distribution channels and, therefore, FDA recommended a seizure action. Dynamic Essentials ceased operation and no longer promotes or sells the products on its website.
In October 2003, FDA refused an entry of 20 kilograms of bulk germanium sesquioxide valued at $16,500, destined for use in human dietary supplements. Germanium has caused nephrotoxicity (kidney injury) and death when used chronically by humans, even at recommended levels of use.
In September 2003, at FDA’s request, the U.S. Marshal seized herbal tea products known as Forticel and Forticel Mix from Jean’s Greens in Norway, New York. The products claimed to treat and cure various life-threatening and serious illnesses such as cancer, thus causing the products to be unapproved drugs. FDA warned Jean’s Greens in November 2001 to change its labeling for the products. The firm failed to comply. The value of the seized goods was more than $4000.
In June 2003, FDA warned consumers not to purchase or consume SIGRA, STAMINA Rx and STAMINA Rx for Women, Y-Y, Spontane ES and Uroprin, manufactured by NVE Pharmaceuticals, Inc., in Newton, New Jersey, and distributed by Hi-Tech in Norcross, Georgia. These products, which were marketed as dietary supplements for sexual enhancement, were found to contain the prescription drug ingredient tadalafil, which can cause a drastic lowering of blood pressure when combined with prescription drugs containing nitrates. Tadalafil is the active ingredient in Cialis, an Eli Lilly product approved in Europe to treat male erectile dysfunction . Despite FDA’s warnings, the defendant and his related businesses repeatedly sold dietary supplements that claimed to treat obesity and erectile dysfunction. Hi-Tech recalled the products and in September 2003, a U.S. District Court Judge entered a Consent Decree of Permanent Injunction enjoining Hi-Tech Pharmaceuticals, National Urological Group, National Institute for Clinical Weight Loss, American Weight Loss Clinic, United Metabolic Research Center, and the President of these corporations, from distributing unapproved new drugs and misbranded drugs.
Global Source and Consulting, Inc.
In June 2003, a U.S. District Court entered a Consent Decree of Condemnation and Destruction for the seized products from Global Source and Consulting, Inc., which included 450 bottles and 57,000 bulk capsules of 20 products marketed as dietary supplement worth $19,000. Global Source agreed to destroy the products and to cease manufacture and marketing of “Vitamin Hut Scientific Cholesterol Support Program” or any similar red yeast rice product containing lovastatin, or any other drug product that is a new drug unless and until an approved new drug application is in effect for such product.
Severe Acute Respiratory Syndrome (SARS)
In May 2003, FDA and FTC warned website operators, manufacturers and distributors to remove misleading or deceptive Internet claims that their products may prevent, treat or cure SARS. An Internet “surf”" conducted by FTC, FDA and the Ontario Consumer and Business Services, found numerous sites promoting a variety of SARS treatment or prevention products. The products include dietary supplements containing ingredients such as colloidal silver, ascorbic acid, beta glucan, pycnogenol, and oregano oil. FDA sent warning letters to 8 Internet firms promoting dietary supplement products to treat or prevent SARS. FTC also notified violative firms that they were subject to possible civil or criminal actions under the FTC Act.
Gero-Vita International, Inc.
In May 2003, the FTC filed a complaint against Glenn Braswell and four of his corporations for making false and unsubstantiated claims that several products marketed as dietary supplements are “scientific breakthroughs” to treat or cure numerous serious medical conditions. FDA provided technical assistance and scientific support to FTC for this action. Products identified in the complaint were: Lung Support Formula, which claimed to cure or ameliorate asthma, emphysema, smoking damage and other respiratory problems; Antibetic Pancreas Tonic, which claimed to treat or cure diabetes and to lower blood sugar levels; and GH3 and GH3 Romanian Youth Formula, which claimed to extend life and prevent or treat Alzheimer’s disease and other forms of dementia; Chitoplex to promote weight loss and reverse obesity without diet or exercise; and Testerex, which claimed to treat erectile dysfunction.
In April 2003, FDA announced that Nature’s Youth, LLC, of Centerville, Massachusetts, voluntarily destroyed approximately 5700 boxes of its product, “Nature’s Youth hGH,” worth $515,000. The action followed FDA’s advisory that the products appeared to be misbranded by labeling that included unsubstantiated “structure/function” claims that the product would, among other things, “improve physical performance, speed recovery from training, increase cardiac output, and increase immune functions.”
In February 2003, FDA investigators found that Ancom Anti-Hypertensive Compound tablets, which were marketed on the Internet and in retail stores as dietary supplements, contained several prescription drug ingredients, including reserpine, diazepam (Valium), promethazine, and hydrochlorothiazide. Best Life International, the manufacturer, ceased distribution and recalled the product. Subsequently in May 2003, Best Life International issued a voluntary recall and warned consumers not to buy or consume its product called Viga. Viga, marketed as a dietary supplement, was found to contain sildenafil, the active ingredient in Pfizer’s Viagra. Sildenafil can cause life-threatening lowering of blood pressure when taken with nitrates.
Yellow Jackets and Black Beauties
In January 2003, FDA and the U.S. Marshal’s Service served an inspection warrant that would allow FDA to witness the voluntary destruction of $4 - 5 million worth of products known as “Yellow Jackets” and “Black Beauties.” The warrant was served at NVE Pharmaceuticals, Inc., the manufacturer of the products, located in New Jersey. A distributor in the Netherlands promoted the products on the Internet as alternatives to street drugs. Yellow Jackets and Black Beauties are street terms for controlled substances and were sold as herbal street drug alternatives. In September 2002, FDA became aware of the tragic death of a 16-year old high school football player who had taken Yellow Jackets. FDA placed the products on Import Alert on October 7, 2002.
On December 16, 2002, U.S. Marshals seized approximately 3,000 bottles of EverCLR, a dietary supplement, valued at more than $100,000. EverCLR was marketed by Halo Supply Company of San Diego, California, as a “natural” treatment for viruses such as the herpes virus and “cold and flu protection.” None of these claims was substantiated. FDA charged that EverCLR was an unapproved and therefore, illegal, new drug because it was promoted to treat and prevent specific diseases. Because EverCLR’s labeling lacked adequate directions for use, FDA also charged that the product was misbranded.
In August 2002, FDA issued a warning letter to Better Way Kids. This firm distributed “Calm Focus,” a product promoted to treat Attention Deficit and Hyperactivity Disorder. Based on claims made for the treatment of disease, FDA charged that the product was an unapproved new drug. The firm corrected its product claims.
U.S. v. Syntrax Innovations, Inc., et. al
U.S. v. Syntrax Innovations, Inc., involved a substance called Triax, marketed by Syntrax as a dietary supplement for the treatment of obesity. FDA scientists determined that the product contained a potent thyroid hormone called tiratricol that, if taken in sufficient quantity, can cause heart attacks and strokes. FDA alleged that Triax could not be a dietary supplement because it was promoted to treat a disease (obesity) and because it did not contain any of the dietary ingredients identified in DSHEA. In February 2001, the court entered an injunction barring the distribution of Triax.
U.S. v. Lane Labs USA, Inc. and Andrew Lane
FDA brought an injunction action against Lane Labs USA, Inc., Andrew Lane, and three of Lane Labs’ products, including its shark cartilage product, BeneFin. Lane Labs claimed that two of these products were dietary supplements, but the company promoted those products for the treatment of cancer and HIV ( human immunodeficiency virus) . The third product is a skin cream promoted for the treatment of skin cancer. FDA contended that the disease claims caused all three of these products to be unapproved, and therefore illegal, new drugs and misbranded drugs. The case is pending before the court for decision.
"The only good is knowledge and the only evil is ignorance." - Socrates
03-12-2011, 11:45 PM
Correct me if I'm wrong, but I seem to remember hearing something from one of the reps on here suggesting that manufacturers will no longer being able to make claims about their products, even if there is research to suggest those claims to be true, unless approved by the FDA to do so (or something to that effect). Otherwise, jail time would ensue for selling tainted "food". But again, I could be wrong (God knows with school I just don't have the time to investigate further)!
03-25-2011, 11:40 PM
03-25-2011, 11:51 PM
03-26-2011, 10:58 AM
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